My Healthy Brain: Preserving and Promoting Brain Health Through Evidence-based Practices

Aging Clinical Trial

Official title:

My Healthy Brain: Preserving and Promoting Brain Health Through Evidence-based Practices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04537728
• Other study ID #: 2019P003657
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this trial is to demonstrate early proof-of-concept for My Healthy Brain, an 8-week group program that directly targets multiple lifestyle factors associated with brain health and prevention of cognitive decline. The investigators will explore the feasibility, acceptability, and effect sizes of improvement in primary lifestyle outcomes as well as secondary outcomes of self-determination and subjective well-being.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Age = 60 years
• English fluency/literacy
• =1 modifiable brain disease risk factor (outlined by JAMA)
• Bluetooth 4.0 enabled smartphone

Exclusion Criteria:

• Diagnosis of dementia; Montreal Cognitive Assessment < 18
• Serious medical illness expected to worsen in next 6 months
• Current suicidal ideation
• Substance abuse
• Untreated serious mental health conditions
• Current use of digital monitoring device (eg. Fitbit)
• Mindfulness practice (> 45 minutes/week) in the last three months

Related Conditions & MeSH terms

• Aging
• Cognitive Decline
• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment
• Old Age; Dementia

Intervention

Behavioral:
• My Healthy Brain Version 2
multimodal lifestyle intervention incorporating mindfulness skills, behavioral principles, and recent research on brain disease risk factors

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Brigham and Women's Hospital, Harvard Medical School (HMS and HSDM)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Credibility and Expectancy Questionnaire (CEQ)	percent of participants that score beyond scale midpoint	Baseline (0 Weeks)
Primary	Client Satisfaction Questionnaire (CSQ-3)	Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction.	Baseline (0 Weeks), Post-Test (8 Weeks)
Primary	Recruitment Feasibility	percent of referred patients meeting criteria to participate	Baseline (0 Weeks)
Primary	Program Acceptability	percent of participants completing at least 6 sessions	Baseline (0 Weeks), Post-Test (8 Weeks)
Primary	Treatment Fidelity	percent of sessions rated as 100% adherent	Baseline (0 Weeks), Post-Test (8 Weeks)
Primary	Assessment Feasibility	percent of post-questionnaires completed	Baseline (0 Weeks), Post-Test (8 Weeks)
Primary	Adherence to Actigraph	percent of participants wearing Actiwatch = 5 days per week	Baseline (0 Weeks), Post-Test (8 Weeks)
Primary	Adherence to Lifestyle Behaviors	percent of participants completing weekly homework	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Change in Healthy Aging	change from baseline to post test; measured by Brain Health Behaviors Checklist	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Mindfulness: Cognitive and Affective Mindfulness Scale	change from baseline to post test; Scores range from 12-48, with higher values reflecting greater mindfulness qualities.	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Mindfulness: Homework log	change from baseline to post test; measured by self-reported number of minutes practiced	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Mindfulness: Five-Facet Mindfulness Questionnaire	change from baseline to post test; Scores range from 15-75, with higher scores indicating greater mindfulness.	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Sleep: Pittsburgh Sleep Quality Index	change from baseline to post test;Total scores range from 0 to 21, with higher scores indicating greater sleep disturbance.	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Sleep: Jenkins Sleep Questionnaire	change from baseline to post test; scores range from 0-20, with higher scores indicating greater sleep disruption.	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Sleep: Actigraph measures of sleep	change from baseline to post test	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Physical Activity: PROMIS Physical Function	change from baseline to post test; scores range from 4-16, with higher scores signifying greater physical function.	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Physical Activity: Godin Leisure Time Exercise Questionnaire	change from baseline to post test; scores range from 0 to no upper limit, with higher scores indicating greater activity level.	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Physical Activity: Rapid Assessment of Physical Activity	change from baseline to post test; the highest score with an affirmative response is used for scoring, with higher scores indicating greater physical activity.	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Physical Activity: Actigraph measures of activity	change from baseline to post test	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Nutrition: Mediterranean Eating Pattern for Americans Screener	change from baseline to post test; scores range from 0-16, with higher scores indicating a greater adherence to the Mediterranean diet.	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Nutrition: MIND Diet Adherence Checklist	change from baseline to post test; scores range greater than or equal to 0, with higher scores indicating creater adherence to MIND diet.	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Medication and Substance Use: Morisky Medication Adherence Scale	change from baseline to post test; scores range from 0-4 with higher scores indicating greater adherence to medication regiment.	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Medication and Substance Use: Alcohol Use Disorders Identification Test-Consumption	change from baseline to post test; Scores range from 0-12, with higher scores indicating more hazardous drinking.	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Medication and Substance Use: Fagerstrom Test for Nicotine Depedence	change from baseline to post test; scores range from 0-10, with higher total scores indicating greater physical dependence on nicotine.	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Stress and Emotional Functioning: Perceived Stress Scale	change from baseline to post test; scores range from 0-40, with higher scores indicating greater perceived stress.	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Stress and Emotional Functioning: PROMIS Depression	change from baseline to post test; scores range from 8-40, with higher scores indicating greater depression.	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Stress and Emotional Functioning: PROMIS Anxiety	change from baseline to post test; scores range from 8-40, with higher scores indicating greater anxiety.	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Stress and Emotional Functioning: Heart Rate Variability (Actigraphy)	change from baseline to post test	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Social Functioning: PROMIS Social Isolation	change from baseline to post test; scores range from 6-30, with higher scores indicating greater social isolation.	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Social Functioning: PROMIS Emotional Support	change from baseline to post test; scores range from 4-16, with higher scores indicating lower emotional support.	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Social Functioning: UCLA Loneliness Scale	change from baseline to post test; scores range from 0-24, with higher scores indicating stronger perceptions of loneliness and social isolation.	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Cognitive Functioning: Everyday Cognition Scale	change from baseline to post test; scores range from 12-60, with higher scores indicating worse cognitive ability to perform everyday tasks.	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Cognitive Functioning: PROMIS Cognition	change from baseline to post test; scores range from 8-40, with higher scores indicating greater patient-perceived cognitive deficits.	Baseline (0 Weeks), Post-Test (8 Weeks)
Secondary	Cognitive Functioning: Montreal Cognitive Assessment	change from baseline to post test; scores range from 0-30, with higher scores representing greater global cognitive capacity.	Baseline (0 Weeks), Post-Test (8 Weeks)